Christine NOIVILLE CNRS / Paris 1 University

1. Biobanks for research. Ethical and regulatory aspects in human biological samples collections in France Christine NOIVILLE CNRS / Paris 1 University

2. Introduction • Biobanking: its significance in modern medical research Collections of human biological samples (tissues, body fluids, DNA…) and related data (clinical, biological, genealogical…) Pathology oriented biobanks / populational biobanks • Biobanking in France biobanks abound  : profusion of samples collections ; networks (Cancer National Institute, Eurobiobank…) special rules for control (declaration/authorization ; ethical review Board) bioethics principles (29 july 1994 law amended 6 august 2004: consent, gratuity, « non-patrimoniality »)

3. Introduction (2) • Main ethical issues CCNE / National Ethics Committee, advice n° 77(20th March 2003) Protecting donors (I) Sharing the content and benefits of biobanks (II)

4. I. Protecting donors Consent • General principles : • informed consent always needed, either express (clinical trial -Opt in) or tacit (healthcare – Opt out) • No blanket consent: opposition right to new research programs • Consent withdrawal • Remaining issues : • Balance between donors’ protection and research needs • right to know / not to know about the results of the research

5. Confidentiality • General rules : • Biobanks must be declared or autorized (research with health data) by CNIL (national authority protecting privacy and personal data) • Identifying data must be encoded (exceptions, e.g. peculiarity of the research) • Commercial exploitation of identifying data is forbidden (13 august 2004 law on health insurance) ; transfer to employers or insurers (article L. 110-4 public health code / 4 march 2002 law) ; criminal sanctions (articles 226-13 et 226-14 criminal code) • Remaining issues : • can courts and police authorities access samples and data for public security reasons ? • profiling whole groups of people

6. II. Sharing the content and benefits of biobanks Access to biological samples • a source of unique biological samples and a powerful tool for research • Public hospitals (APHP) / Health Research Institute (INSERM) conflict • Collection value : necessity to recognize each protagonist’s added value (doctors, researchers, facilities hosting collections, firms…) • Property rights : limits of exclusive property as regards access imperative • CCNE’s advice n°77 : invent a new legal concept that guaranties access

7. Sharing benefits with donors ? • Donors’ right to get a return if a product is developed with their samples ? • US: John Moore case; France: donors have no property rights on their samples • Benefit sharing should be conceived in a collective and non financial manner. • Donors contribute to science altruistically // biobanks increasingly involve researchers, biotech firms and pharma companies which aim to profit by these donations. • Resources must be exploited in a way that favors donors’ interests. • Rules have been adopted in order to protect donors’ interests (patent rules preventing too large monopolies blocking research ; rules guarantying patients’ access to important patented medicines).

8. Conclusion Biobanking activities may proceed only if : • Rights and obligations of all stakeholders (donors, researchers, facilities, industry…) are clearly addressed and regulated • They remain in line with french ethical values (consent, altruism) and with their very original aim (research, public health improvement).